Bigger fees to speed FDA reviews

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Like others in the orthopedic devices industry, Zimmer Holdings Inc. has followed the agreement’s progress.
Garry Clark, Zimmer spokesman, expressed support for the deal that calls for medical device manufacturers to pay the Food and Drug Administration more in exchange for faster approvals.
“Zimmer believes this agreement provides FDA with the resources needed to make the medical device review process more predictable, consistent and effective, and looks forward to working with industry and Congress to make sure FDA is held accountable for its performance under the new agreement,” Clark said in an email to The Journal Gazette.
– Sherry Slater, The Journal Gazette

WASHINGTON – Medical device makers will double the fees they pay federal regulators to get products reviewed over the next five years, to $595 million, in a deal designed to secure faster and more predictable evaluations.

The Food and Drug Administration announced the agreement Wednesday. The pact, which must be authorized by Congress, replaces one that cost Medtronic Inc., Johnson & Johnson and other device makers $287 million over the last five years and expires Sept. 30. Johnson & Johnson is the parent of Warsaw-based DePuy Orthopaedics.

The new agreement, which is still being finalized, would allow the FDA to hire 200 full-time employees by the end of the five-year program, the agency said in a statement.

It requires FDA evaluators to meet midway through reviews with device applicants to give the companies time to address concerns and sets goals for the agency to finish reviews faster, according to a statement from the Advanced Medical Technology Association, the device industry’s Washington lobby.

“If this is tied to faster, better visibility, more efficiency, it’s worth its weight in gold,” Thomas Gunderson, a Piper Jaffray & Co. analyst based in Minneapolis, said of the fee deal.

One of the biggest barriers to medical device investment has been the FDA’s slow approval process, particularly in the last three years, Gunderson said.

The industry has been seeking more meetings with FDA staff during reviews to head off 11th-hour requests for safety data that companies said were delaying approvals, even with the fee system. The sides had traded proposals for how much such a system would cost.

“The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process,” Stephen Ubl, AdvaMed president and chief executive officer, said in the statement.